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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 6, 2013 SORRENTO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) 6042 Cornerstone Ct. West, Suite B San Diego, CA 92121 (Address of principal executive offices) Registrant’s telephone number, including area code: (858) 210-3700 (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: Delaware 000-52228 33-0344842 (State or other jurisdiction of incorporation or organization) (Commission File Number) IRS Employer Identification No.) Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Transcript of SORRENTO THERAPEUTICS, INC.sorrentotherapeutics.com/wp-content/uploads/2013/06/548180_8K_… ·...

Page 1: SORRENTO THERAPEUTICS, INC.sorrentotherapeutics.com/wp-content/uploads/2013/06/548180_8K_… · CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 6, 2013

SORRENTO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

6042 Cornerstone Ct. West, Suite B San Diego, CA 92121

(Address of principal executive offices)

Registrant’s telephone number, including area code: (858) 210-3700

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Delaware 000-52228 33-0344842(State or other jurisdiction of

incorporation or organization) (CommissionFile Number)

IRS Employer Identification No.)

� Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

� Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

� Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

� Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Sorrento Therapeutics, Inc. (the “Company”) intends to conduct meetings with third parties in which its corporate slide presentation will be presented. The Company’s presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any registration statement filed under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference therein.

(d) Exhibits.

Item 7.01. Regulation FD Disclosure.

Item 9.01. Financial Statements and Exhibits.

99.1 Sorrento Therapeutics, Inc. Company Presentation.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: June 6, 2013

SORRENTO THERAPEUTICS, INC.

By: /s/ Richard Vincent Name: Richard VincentTitle: Chief Financial Officer and Secretary

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Sorrento Therapeutics, Inc. (STI)

Next-GenerationTargeted and Personalized

Cancer Therapeutics

Jefferies 2013 Global Healthcare Conference

June 6, 2013

Exhibit 99.1

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Safe Harbor Statement OTC Symbol: SRNE

Pro Forma forMerged Sorrento + IGDRASOL

This presentation contains "forward-looking statements," as that term is defined under the PrivateSecurities Litigation Reform Act of 1995 (PSLRA), including statements regarding expectations, beliefs or intentions regarding our business, technologies and products strategies or prospects. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to,

the possibility that some or all of the pending matters and transactions being considered by the Company may not proceed as contemplated, and by all other matters specified in Company's filings withthe Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining

regulatory approvals of new, commercially-viable and competitive products and product candidates. These statements are made based upon current expectations that are subject to risk and uncertainty and information available to the Company as of the date of this presentation. The company does not

undertake to update forward-looking statements in this presentation to reflect actual results, changes inassumptions or changes in other factors affecting such forward-looking information. Assumptions and

other information that could cause results to differ from those set forth in the forward-looking informationcan be found in the Company's filings with the Securities and Exchange Commission, including its most

recent periodic report. We intend that all forward-looking statements be subject to the safe-harborprovisions of the PSLRA.

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Oncology Product Candidates

G-MAB®Immuno-therapy mAbs

Cynviloq™ Phase 3Ready

AfDC Next-GenADC

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TUMOR

Abraxane®

ADC(Adcetris®, Kadcyla™ )

Combo Therapy (Abraxane® + Avastin®)

The Target Oncology Markets

mAb (Avastin®, Herceptin®, Yervoy®)

+

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Significant Value Drivers

Abraxis/Celgene

GenentechCambridge Antibody Technology

Seattle Genetics (SGEN): ~$4B Market CapImmunogen (IMGN): ~$1.5B Market Cap

Abraxane®

MBC approval

Abraxis acq’d by Celgene for $3B+

Abraxane®

NSCLC approval

Abraxane®

MBC sales: $427M

Abraxane® PC approval (exp’d)

2005 2010 2012 2013

Genentech acq’d by Roche for ~$106B

Avastin® + Herceptin®(~$12B)Humira® (~$10B)

2009 2013

Adcetris®

approval

20132011

KADCYLA®

approval

2006

CAT acq’d byAZ for $1.3B

Abraxane ®

mAbs

ADC

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TUMOR

G-MAB®

Cynviloq™ + G-MAB®

Next Generation Cancer Therapeutics

Cynviloq™

• High-diversity, human Ab library• 10+ lead mAb programs• Immunotherapies

(Oncology, non-oncology and rIVIG)• FTO and no stacking royalty

• Paclitaxel polymeric micelle

• Phase 3-ready• Competitive vs.

Abraxane®

• Single source • Combination therapy• No stacking royalty

• Single source• G-MAB® or biosimilar mAbs• Proprietary formulation

+

AfDC: Antibody formulated Drug Conjugate

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INDICATION

INDICATION > TARGET

G-MAB®

Metastatic Breast Cancer (505(b)(2) BE)*

Non-Small Cell Lung Cancer (505(b)(2) BE)*

Bladder Cancer (sNDA)

Ovarian Cancer (sNDA)

Pancreatic Cancer (505(b)(2) BE)*

Oncology > PD-L1, PD-1, other

Inflammation > PD-L1, CCR2, other

Infectious Disease > MRSA

Q4 2013

Q4 2013

H1 2015

H1 2015

AfDC Oncology > c-Met, CXCR5, other

Q4 2013 H1 2015

* Subject to EOP2 meeting with FDA scheduled for Q3 2013

Multiple Strategic Partnership Opportunities

H1 2014 2016

H1 2015

H2 2015

Pipeline

Cynviloq™

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Management Team

8

Henry Ji, Ph.D.President, CEO & Director

• Inventor of STI G-MAB® Technology• President & CEO of Stratagene Genomics• VP of CombiMatrix and Stratagene

CombiMatrix, Stratagene,Stratagene Genomics, Human Genome Sciences

Vuong Trieu, Ph.D.Chief Scientific Officer

• Founder and CEO of Igdrasol• Instrumental in the approval of Abraxane®

• Co-inventor of IP covering Abraxane®

• Led and developed the pipeline for Abraxis Biosciences resulting in its sale for $2.9B

Abraxis BioScience (ABI), Celgene, AME (Eli Lilly), Genetic Therapy Inc. (Novartis)

George UyChief Commercial Officer

• Directed the highlysuccessful launch of Abraxane®, Xeloda® & Fusilev ®

• Built commercial infrastructures and organizations in startup companies

ABI, Spectrum Pharma, Hana Biosciences, Roche

Jaisim ShahChief Business Officer

• $430M sale of Elevation Pharmaceuticals to Sunovion-Dainippon

• $1.15B PDL-BMS global collaboration • $800M PDL-Biogen Idec collaboration• $200M sale iv Busulfex to Otsuka

Elevation, Roche, BMS, Facet Biotech, PDL, Cytrx, Zelos

Richard VincentCFO and Director

• $430M sale of Elevation to Sunovion-Dainippon • Meritage Pharma option agreement with ViroPharma

($90M upfront + milestones)• $310M sale of Verus Asthma program to AZ• Elan: various acquisitions and divestitures with

aggregate values in excess of $300M

Elevation, Meritage, Suneva Medical, Verus, Women First Healthcare, Elan, Phase Metrics, Deloitte & Touche

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Oncology Franchise

Phase 3 candidateCynviloq™

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What is Cynviloq™? Proprietary Paclitaxel Polymeric Micelle

paclitaxel

Poly(ethylene glycol)hydrophilic shell

Poly(D,L-Lactide)hydrophobic core

Cynviloq™10

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Mean size80 nm

Cynviloq™paclitaxel

polymeric micelle

Chemical polymer: Poly-lactide and polyethylene glycol diblock copolymer

Mean size130 nm

Biological polymer: Donor-derived human serumalbumin (HSA)

260 mg/m2

Taxol ®

paclitaxel Cremophor EL excipient:Polyoxyethylatedcastor oil

FormulationGeneration

175 mg/m2

Maximum Tolerated Dose (MTD)

Evolution of Paclitaxel Therapy

11

1

2

3

Abraxane®

-paclitaxel

300 mg/m2

st

nd

rd

nab

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Cynviloq™ Taxol® Abraxane® Cynviloq™Advantage

Maximum ToleratedDose (mg/m2)

>300 175 260Potential for higher efficacy

Rapid reconstitution: no foaming concerns

Convenience for busy practices and pharmacies

No donor-derived human serum albumin (HSA)

No viral / prion concerns

Convenient storage conditions

No requirement for controlled temp storage

No microbial growth Chemical polymer

Cremophor-free Reduced side effects

Advantages vs. Competitors: Taxol® & Abraxane®

Taxol® is a registered trademark with Bristol-Myers-Squibb. Abraxane® is a registered trademark with Celgene.

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• >300 mg/m² (q3w) vs. 175 mg/m² (Taxol ®; weekly) and 275 mg/m² (Abraxane ®; q3w)

• Data suggestive of efficacy comparable to historic data for Abraxane® and superior to historic Taxol® data or Standard-of-Care

• Possible Phase 3 sNDA programs in these tumor types

• GPMBC301. An Open-label, Randomized, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of Genexol-PM® Compared to Genexol® (Paclitaxel with Cremophor EL) in Subjects with Recurrent or Metastatic BC; n=105(Genexol-PM ®); n=104 (Genexol ®)

• Interim analysis suggests ORR superior to Taxol® and comparable to historicAbraxane ® efficacy

• Efficacy and safety data supportive of 505(b)(2) BE submission

• Efficacy and safety data supportive of 505(b)(2) BE submission

Clinical Efficacy & Safety Summary

Cancer Center, Russia, S. Korea)

Trials established higher MTD (total n=80; in US - Dana Farber Cancer Inst., Russia, S. Korea)

Completed trials in MBC, NSCLC, PC, OC, BC (total n=259; in US – YalePhase 2:

Phase 1:

Ongoing trial for MBC (n=209; in S. Korea)Phase 3:

Completed for MBC and NSCLC (total n=502)PM-Safety:

Total number of patients across all trials: 946

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Comparison of Clinical Efficacy in MBC: Phase 3 Trials

Overall Response

Rate(%)

US approval for Abraxane ® in MBC and NSCLC for non-inferiority against Taxol ® based on ORR * No obvious ethnic differences seen between ORR in trials* Interim data from trial; OS and PFS analyses ongoing

United States

Cynviloq™ Taxol® Abraxane®

CA012Abraxane®

CA201Taxol® Taxol®

ChinaSouth Korea*

p = 0.03 p = 0.001 p = 0.025

0

5

10

15

20

25

30

35

40

45

n=105 n=104 n=209 n=205 n=81 n=82

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Abraxane® nanoparticlesat concentrations above its critical micelle concentration*

* Data on fileFBS = fetal bovine serum

Paclitaxel released from both formulations binds to albumin in the bloodand exploits albumin-transport pathway into the tumor

Cynviloq™ polymeric micelles at concentrations above its critical micelle concentration*

Absence of nanoparticles at physiological concentration

Absence of nanoparticles atphysiological concentration

Size (nm)

Nanoparticle Disintegration

Size (nm)

g/mL

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16Cynviloq™ data on file* Gardner et all, 2008

• PK BE was calculated as 95% confidence interval (CI)

• Ratio T/R (Cmax and AUCinf) within 80-125% (90% CI)

Comparison of mean non-compartmental pharmacokinetic parameters ofCynviloq™ (T) and Abraxane® (R) @ 260 mg/m

2with 30 min infusion time:

Cmax

(ng/mL)

Ratio

Cmax(T)/Cmax(R)

AUCinf

(ng*h/mL)

Ratio

AUCinf(T)/AUCinf(R)

CynviloqTM

(Simulated PK)19486

99.6%22198

109.2%Abraxane®

(Actual PK)*19556 20324

Simulated PK Parameters Supportive of 505(b)(2) BE: Cynviloq™ vs. Abraxane®

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••

• EOP2 meeting with FDA to discuss BE protocol and site selection (Q3 2013)

• Initiate BE studies (Q4 2013)- One cross-over study (n=66) at dose of 260 mg/m

2

- 12 months duration

- ~$3M

• NDA filing (H1 2015)

• FDA approval for all current (H1 2016 for MBC and NSCLC) and future Abraxane® (PC and MM) indications

STI’sBusiness Strategy

505(b)(2) BE Timeline

17

BE Registration Trial and Commercial Launch for MBC / NSCLC

EU Rights for Partnership

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Cynviloq™Phase 2 (Korea)*

n=34#

Best Supportive Care (BSC)Phase 2 (Japan) **/ Phase 3 (EU)***

n=23** / n=108***

2 line 260 mg/m (cycle 1)

300 mg/m (cycles 2-4)q3w

Designed to prevent and control the side effects ofcancer and its treatment

Overall Response Rate 21% - / 0%***

Progression Free Survival 2.7 M - / 1.5 M***

Overall Survival 6.5 M 2.3 M** / 4.3 M***

* Invest New Drugs (2012) 30:1984–1990# advanced urothelial carcinoma patients refractory to gemcitabine and cisplatin** AUA- San Diego May4th-8 th; *** JCO (2009): 4454-61

Summary:• High unmet need with no FDA approved 2nd line drug • Generally well-tolerated and demonstrated clinical ORR• Phase 3-ready for development as 2nd line chemotherapy in patients

refractory to platinum-based therapy

Cynviloq™Bladder Cancer - vs. Historic BSC

Clinical Experience:

2

2

nd

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• Registration Trial and Commercial Launch for BC

• EU Rights for Partnership

STI’sBusiness Strategy

sNDA Timeline for Bladder Cancer

• Phase 3 study preparation (Q3 2013)- No approved 2nd line treatment; ~15,000 deaths annually (US)

• Orphan Drug Status Designation (Q4 2013)- 7-year marketing exclusivity

- Enhanced R&D credit

• “First Patient In” (H1 2014)- n=400 (~200 patients each arm) vs. BSC

- 18-24 months duration

- $20M

• 505(b)(2) sNDA filing for 2nd line treatment (H1 2016)

19

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Therapeutic Antibody Engine

G-MAB®Immuno-therapy

mAb candidates

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• Proprietary amplification– RNA amplification for

variable domains

STI Technology

• Very high diversity:

VH: 7.1 x 107

VL: 2.9 x 10 8

Combined: 2.1 x 1016

• High successful hit rate

Library Quality

• FTO

• Issued and pending patents on G-MAB®

library and individual mAbs

• No royalty burden

Intellectual Property

G-MAB® Library

Difficult targets: GPCR

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Potent mAbs Generated From G-MAB® Library

Difficult Targets:Small Molecules

Low molecular weight antigens (< 2,500 Da; “haptens”)

Validated and/or Hot Targets: Medium-sized antigens

Soluble protein ligandsor cell surface receptors

Most Difficult Targets: Large Complex Molecules

G protein-coupled receptors (GPCRs)

• Auto-Inducing Peptides (AIPs) - Methicillin-resistant S. aureus (MRSA)- Clostridium difficile (C.diff)

• PD-L1• PD-1• c-Met• VEGFR2• EGFR• ErbB3

• CCR2• CCR6• CXCR3• CXCR5

Size of Target Antigen

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Days After Disease Induction

STI-B0201 (D1) - prophylactic

STI-B0201 (D1) - therapeutic

PBS

Inflammation: Anti-CCR2 mAb Efficacious in Multiple Sclerosis (EAE) Model

Summary:• STI-B0201 identified from G-MAB® library has superior binding properties to CCR2 compared to competitor mAb

• STI-B0201 stabilizes disease when given prior to or after onset of symptoms

mAb Cell Binding - hCCR2 (EC50 – nM)

STI-B0201 (D1) 0.17

MLN1202 21

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Immunotherapy: Anti-PD-L1 mAbs Exhibit PotentImmune Modulation In Vitro

Summary:STI anti-PD-L1 mAbs identified from G-MAB® library at least as potent as competitor’s mAb (best listed in patent)

C)

Anti-PD-L1 mAbs trigger:A) Enhancement of T cell activationB) Increased interleukin-2 (IL-2) C) Increased interferon- (IFN- )

A)

B)

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Immunotherapy: Anti-PD-1 mAbs Exhibit Potent Immune Modulation In Vitro

Summary:STI anti-PD-1 mAbs identified from G-MAB® libraryat least as potent as competitor’s mAb (best listed in patent)

B) C)

A)

Anti-PD-1 mAbs trigger:A) Enhancement of T cell activationB) Increased interleukin-2 (IL-2) C) Increased interferon- (IFN- )

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26Multiple Strategic Partnership Opportunities

ONCOLOGY

PD-L1

INFLAMMATION

ONCOLOGY /INFLAMMATION

(GPCR)

INFECTIOUSDISEASE

PD-1

c-Met

VEGFR2

EGFR

ErbB3

PD-L1

RAGE

CGRP

CCR2

CXCR3

CXCR5

MRSA

CCR6

(STI-A100X)

(STI-A110X)

(STI-A060X)

(STI-A020X)

(STI-A050X)

(STI-B010X)

(STI-B120X)

(STI-B150X)

(STI-B020X)

(STI-A120X)

(STI-B030X)

(STI-C020X)

(STI-B100X)

(STI-A0168)

H1 2015

H2 2015

G-MAB® Pipeline

H1 2015

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Antibody formulated Drug Conjugate (AfDC)

AfDC Next-GenADC

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AfDC Advantage

Requires:• Prodrug synthesis

• Linker chemistry

• ADC internalization

Drug released in cancer cell

Enables:• Single source

• Drug formulation

• mAb-payload combinations

Drug released in TUMOR

28

ADC AfDC

STI’sBusiness Strategy

• Advance 1 AfDC Project/Year to Clinical Proof-of-Concept

• Strategic Partnerships

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Xenograft model – 5x10 6 U118 human glioblastoma cells

treatment initiated

Days After Tumor Inoculation

STI-A0601 (A1)

STI-A0602 (E1)

STI-A0603 (H8)

PBS

Oncology: Anti c-Met mAbs Exhibit PotentAnti-Tumor Activity In Vivo

Summary:STI mAbs identified from G-MAB® library all

demonstrate potent suppression of tumor growth.

0

100

200

300

400

500

600

700

800

900

1000

7 10 12 14 17 19 21 24 26 28 31 33 35

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AfDC Opportunities

Multiple Strategic Partnership Opportunities

B-W-B (Bio-Way-Better) Candidates

EGFR (Erbitux®)

Her2 (Herceptin®)

CD20 (Rituxan®)

VEGFR2

EGFR

c-Met

ErbB3

IGF-1R

CXCR5

CXCR3

BiosimilarmAb

G-MAB®

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Positioning to Become an Oncology Leader

Cynviloq™

G-MAB®

AfDC Next-GenADC

Immuno-therapy mAbs

Phase 3 Ready

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Sorrento Therapeutics, Inc. (SRNE)

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Sorrento Therapeutics, Inc. (SRNE)

Next-GenerationTargeted and Personalized

Cancer Therapeutics

Contact:Henry Ji

President and [email protected]

(858) 668-6923